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Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research (DREPACORD)

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ClinicalTrials.gov Identifier: NCT03876821
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Centre Hospitalier Sud Francilien
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.

Condition or disease
Sickle Cell Disease

Detailed Description:
Pregnant individuals carrying at least one HbS allele will be included in the study to collect the umbilical cord blood of the child at birth. Collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of samples with HbS/HbS genotype [ Time Frame: 3 years ]
    Measured by DNA sequencing


Secondary Outcome Measures :
  1. Number of samples with bio-experimental data [ Time Frame: 4 years ]
    Consisting of cellular characterization, transduction and cell processing data


Biospecimen Retention:   Samples With DNA
DNA from cord blood cells.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Giving birth
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study includes pregnant women, aged 18-45 years of age, carrying at least one HbS allele, and who are followed and giving birth at the maternity unit of the Centre Hospitalier Sud Francilien in Evry, France.
Criteria

Inclusion Criteria:

  • Pregnant women, giving birth at CHSF and consenting to the collect and study of placental blood after delivery
  • Age 18 to 45 years
  • Biological testing of the participant includes hemoglobin electrophoresis and shows at least one HbS allele

Exclusion Criteria:

  • Lack of written consent
  • Minors (not 18 years old) or under guardianship
  • Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876821


Contacts
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Contact: Ismahane GUIMIOT +33 (0)1 82 53 35 36 ismahane.guimiot@inserm.fr

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Centre Hospitalier Sud Francilien
Investigators
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Principal Investigator: Luc Rigonnot, MD CHSF
Study Director: Anne Galy, PhD Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03876821     History of Changes
Other Study ID Numbers: C18-31
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn